U.S. patent application number 13/643350 was filed with the patent office on 2013-08-15 for nutritional compositions and methods for weaning from parenteral nutrition to enteral nutrition.
This patent application is currently assigned to NESTEC S.A.. The applicant listed for this patent is Norman Alan Greenberg, Claudia Roessle. Invention is credited to Norman Alan Greenberg, Claudia Roessle.
Application Number | 20130210715 13/643350 |
Document ID | / |
Family ID | 44320366 |
Filed Date | 2013-08-15 |
United States Patent
Application |
20130210715 |
Kind Code |
A1 |
Greenberg; Norman Alan ; et
al. |
August 15, 2013 |
NUTRITIONAL COMPOSITIONS AND METHODS FOR WEANING FROM PARENTERAL
NUTRITION TO ENTERAL NUTRITION
Abstract
Nutritional compositions and methods of using the nutritional
compositions are provided. In a general embodiment, the present
disclosure provides a nutritional composition including one or more
proteins, one or more amino acids and one or more exogenous
nucleotides. The nutritional compositions can be specifically used
to assist a patient in weaning from partial or total parenteral
nutrition to enteral nutrition with improved tolerance.
Inventors: |
Greenberg; Norman Alan; (New
Hope, MN) ; Roessle; Claudia; (Morges, CH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Greenberg; Norman Alan
Roessle; Claudia |
New Hope
Morges |
MN |
US
CH |
|
|
Assignee: |
NESTEC S.A.
Vevey
CH
|
Family ID: |
44320366 |
Appl. No.: |
13/643350 |
Filed: |
April 25, 2011 |
PCT Filed: |
April 25, 2011 |
PCT NO: |
PCT/US11/33729 |
371 Date: |
December 20, 2012 |
Current U.S.
Class: |
514/5.6 ;
514/5.7 |
Current CPC
Class: |
A61P 3/02 20180101; A23L
33/17 20160801; A23L 33/40 20160801; A61K 9/0029 20130101; A23L
33/13 20160801; A23L 33/19 20160801; A23L 33/175 20160801; A23L
33/18 20160801; A23L 33/185 20160801 |
Class at
Publication: |
514/5.6 ;
514/5.7 |
International
Class: |
A61K 9/00 20060101
A61K009/00; A23L 1/29 20060101 A23L001/29 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 26, 2010 |
US |
61327883 |
Mar 1, 2011 |
US |
61448171 |
Mar 22, 2011 |
US |
61466017 |
Claims
1. A nutritional composition comprising a protein, an amino acid
and an exogenous nucleotide: the protein comprising from about 35%
to about 55% of total energy of the nutritional composition and is
selected from the group consisting of an intact protein, free amino
acids, a whey protein hydrolysate, casein hydrolysate, milk protein
hydrolysate, soy protein hydrolysate, pea protein hydrolysate, and
combinations thereof; the amino acid comprises from about 20 grams
to about 40 grams and is selected from the group consisting of a
glutamine source, a threonine source, a cysteine source, a serine
source, a proline source, and combinations thereof; and the
exogenous nucleotide comprises about 1 to about 4 grams.
2. The nutritional composition according to claim 1, wherein the
glutamine source is selected from the group consisting of a
glutamine dipeptide, a glutamine enriched wheat protein, and
combinations thereof.
3. The nutritional composition according to claim 1, wherein the
exogenous nucleotide is in a monomeric form selected from the group
consisting of 5' Adenosine Monophosphate, 5'-Guanosine
Monophosphate, 5'-Cytosine Monophosphate, 5'-Uracil Monophosphate,
5'-Inosine Monophosphate, 5'-Thymine Monophosphate, and
combinations thereof.
4. The nutritional composition according to claim 1, wherein the
exogenous nucleotide is intact ribonucleic acid.
5. The nutritional composition according to claim 1, comprising at
least one component selected from the group consisting of: lipids,
carbohydrates, antioxidants, vitamins, minerals, fiber, synbiotics,
probiotic, phytonutrients, and combinations thereof.
6. The nutritional composition according to claim 5, wherein the
lipid is selected from the group consisting of short chain
triglycerides, medium chain triglycerides, long chain
triglycerides, fish oil, vegetable oil, and combinations
thereof.
7. The nutritional composition according to claim 5, wherein the
fiber is selected from the group consisting of
galacto-oligosaccharides, fructo-oligosaccharides,
fuco-oligosaccharides, xylo-oligosaccharides,
palatinose-oligosaccharide, soybean oligosaccharide,
gentio-oligosaccharide, inulin, pectin, pectate, alginate,
chondroitine, hyaluronic acids, heparine, heparane, sialoglycans,
fucoidan, carrageenan, xanthan gum, cellulose, polydextrose,
partially hydrolyzed guar gum, guar gum, and combinations
thereof.
8. The nutritional composition according to claim 5, wherein the
probiotic is selected from the group consisting of Saccharomyces,
Debaromyces, Candida, Pichia, Torulopsis, Aspergillus, Rhizopus,
Mucor, Penicillium, Torulopsis, Bifidobacterium, Bacteroides,
Clostridium, Fusobacterium, Melissococcus, Propionibacterium,
Streptococcus, Enterococcus, Lactococcus, Staphylococcus,
Peptostrepococcus, Bacillus, Pediococcus, Micrococcus, Leuconostoc,
Weissella, Aerococcus, Oenococcus, Lactobacillus, and combinations
thereof.
9. A method of making a nutritional composition, the method
comprising: combining protein, amino acid and endogenous nucleotide
in a ratio so that the protein comprises from about 35% to about
55% of total energy of the nutritional composition and is selected
from the group consisting of an intact protein, free amino acids, a
whey protein hydrolysate, casein hydrolysate, milk protein
hydrolysate, soy protein hydrolysate, pea protein hydrolysate, and
combinations thereof, the amino acid comprises from about 20 grams
to about 40 grams and is selected from the group consisting of a
glutamine source, a threonine source, a cysteine source, a serine
source, a proline source, and combinations thereof, and the
exogenous nucleotide comprises about 1 to about 4 grams to form a
nutritional composition.
10. The method as claimed in claim 9, comprising combining at least
one component selected from the group consisting of: lipids,
carbohydrates, antioxidants, vitamins, minerals, fiber, synbiotics,
probiotic, phytonutrients, and combinations thereof.
11. The method according to claim 9, wherein the nutritional
composition is in an administerable form selected from the group
consisting of pharmaceutical formulations, nutritional
formulations, dietary supplements, functional foods, beverage
products, and combinations thereof.
12. A method of providing nutrition to a patient, the method
comprising: providing parental nutrition to a patient; and
administering to the patient having previously received nutrition
parenterally a weaning nutritional composition comprising a
protein, an amino acid and an exogenous nucleotide, the protein
comprising from about 35% to about 55% of total energy of the
nutritional composition and is selected from the group consisting
of an intact protein, free amino acids, a whey protein hydrolysate,
casein hydrolysate, milk protein hydrolysate, soy protein
hydrolysate, pea protein hydrolysate, and combinations thereof, the
amino acid comprises from about 20 grams to about 40 grams and is
selected from the group consisting of a glutamine source, a
threonine source, a cysteine source, a serine source, a proline
source, and combinations thereof, and the exogenous nucleotide
comprises about 1 to about 4 grams.
13. The method according to claim 12, wherein the glutamine source
is selected from the group consisting of a glutamine dipeptide, a
glutamine enriched wheat protein, and combinations thereof.
14. The method according to claim 12, wherein the exogenous
nucleotide is in a monomeric form selected from the group
consisting of 5' Adenosine Monophosphate, 5'-Guanosine
Monophosphate, 5'-Cytosine Monophosphate, 5'-Uracil Monophosphate,
5'-Inosine Monophosphate, 5'-Thymine Monophosphate, and
combinations thereof.
15. The method according to claim 12, wherein the exogenous
nucleotide is intact ribonucleic acid.
16. The method according to claim 12, wherein the weaning
nutritional composition further comprising at least one component
selected from the group consisting of lipids, carbohydrates,
antioxidants, vitamins, minerals, fiber, synbiotics, probiotic,
phytonutrients, and combinations thereof.
17. The method according to claim 16, wherein the lipid is selected
from the group consisting of short chain triglycerides, medium
chain triglycerides, long chain triglycerides, fish oil, vegetable
oil, and combinations thereof.
18. The method according to claim 16, wherein the fiber is selected
from the group consisting of galacto-oligosaccharides,
fructo-oligosaccharides, fuco-oligosaccharides,
xylo-oligosaccharides, palatinose-oligosaccharide, soybean
oligosaccharide, gentio-oligosaccharide, inulin, pectin, pectate,
alginate, chondroitine, hyaluronic acids, heparine, heparane,
sialoglycans, fucoidan, carrageenan, xanthan gum, cellulose,
polydextrose, partially hydrolyzed guar gum, guar gum, and
combinations thereof.
19. The method according to claim 16, wherein the probiotic is
selected from the group consisting of Saccharomyces, Debaromyces,
Candida, Pichia, Torulopsis, Aspergillus, Rhizopus, Mucor,
Penicillium, Torulopsis, Bifidobacterium, Bacteroides, Clostridium,
Fusobacterium, Melissococcus, Propionibacterium, Streptococcus,
Enterococcus, Lactococcus, Staphylococcus, Peptostrepococcus,
Bacillus, Pediococcus, Micrococcus, Leuconostoc, Weissella,
Aerococcus, Oenococcus, Lactobacillus, and combinations
thereof.
20. The method according to claim 12, comprising administering
about 500 mL to about 1000 ml of the weaning nutritional
composition during an initial 24 hour period before enterally
administering longer term an enteral nutritional composition.
21. The method according to claim 12 wherein the patient is weaned
from total parenteral nutrition administration to total enteral
nutrition administration.
22. The method according to claim 12, wherein the nutritional
composition is in an administerable form selected from the group
consisting of pharmaceutical formulations, nutritional
formulations, dietary supplements, functional foods, beverage
products, and combinations thereof.
Description
BACKGROUND
[0001] The present disclosure generally relates to health and
nutrition. More specifically, the present disclosure relates to
nutritional compositions for weaning from total parenteral
nutrition to enteral nutrition and methods of making and using the
nutritional compositions.
[0002] There are many types of nutritional compositions currently
on the market. Nutritional compositions can be targeted toward
certain consumer types, for example, young, elderly, athletic,
etc., based on the specific ingredients of the nutritional
composition. Nutritional compositions can also be formulated based
on the certain physiological conditions that the nutritional
compositions are intended to treat or improve.
[0003] The use of partial parenteral nutrition or total parenteral
nutrition occurs when a patient is unable to consume food orally
and the gastrointestinal ("GI") tract is not able to tolerate
enteral tube feeding. This is usually due to hemodynamic
instability. This refers to unstable blood pressure, especially
dangerously low blood pressure, also called hypotension, which can
involve a lack of blood flow to support the various organs in the
body.
[0004] There are also certain medical conditions where the
intestinal tract should not be used, which include, for example,
healing of an anastomosis, or other GI surgeries, or severe
inflammatory bowel disease such as acute flare-ups of Crohn's
Disease. It is also necessary to use parenteral nutrition for
patients with short bowel syndrome if extensive diarrhea has
occurred so that the patient receives adequate nutrition and
fluids.
[0005] During the time when the GI tract is not used, it atrophies
in the same way that other unused body parts atrophy with disuse.
This disuse causes the GI tract to potentially become a source of
infection due to the reduction in GI tract integrity. To alleviate
this risk and to provide better support to the immune components in
the GI tract, it is accepted clinical practice to provide enteral
feeding as soon as the patient is able to tolerate it.
[0006] Currently, there is no specific formula that is designed to
wean patients from total parenteral nutrition to enteral nutrition.
The present practice is to use a slow rate of feeding into the GI
tract. Nevertheless, the patient can suffer from GI problems during
the switch from total parenteral nutrition to enteral
nutrition.
SUMMARY
[0007] Nutritional compositions for weaning from parenteral
nutrition to enteral nutrition and methods of making and using the
nutritional compositions are provided. In a general embodiment, the
present disclosure provides a nutritional composition including one
or more proteins, one or more amino acids and one or more exogenous
nucleotides. For example, the nutritional composition includes
ingredients that support the repair, function, and reversion of
atrophy of the small bowel in particular, as well as other
ingredients that support the repair, function, and reversion of
atrophy of the large bowel, which can assist the transition of a
patient from partial parenteral nutrition or total parenteral
nutrition to enteral nutrition. As a result, the transition can
occur more efficiently (e.g., less diarrhea, better tolerance, and
targeted enteral feeding goals can be achieved more rapidly).
[0008] In an embodiment, the protein is an intact protein, free
amino acids, a whey protein hydrolysate, casein hydrolysate, milk
protein hydrolysate, soy protein hydrolysate, pea protein
hydrolysate or a combination thereof. The protein can range from
about 35% to about 55% of the total energy of the nutritional
composition. Offering a patient different types of proteins can
optimize absorption.
[0009] In an embodiment, the amino acid is provided by a glutamine
source, a threonine source, a serine source, a proline source, a
cysteine source or a combination thereof. The glutamine source can
be a glutamine dipeptide and/or glutamine enriched wheat protein.
The amino acid can be in an amount from about 20 grams to about 40
grams in the nutritional composition.
[0010] In an embodiment, the exogenous nucleotide is in a monomeric
form such as 5' Adenosine Monophosphate, 5'-Guanosine
Monophosphate, 5'-Cytosine Monophosphate, 5'-Uracil Monophosphate,
5'-Inosine Monophosphate, 5'-Thymine Monophosphate or a combination
thereof. The exogenous nucleotide can also be intact ribonucleic
acid. The exogenous nucleotide can be in an amount of about 1 to
about 4 grams in the nutritional composition.
[0011] In an embodiment, the nutritional composition includes one
or more lipids. The lipid can be short chain triglycerides, medium
chain triglycerides, long chain triglycerides, fish oil, vegetable
oil or a combination thereof. In an embodiment, the lipids include
tributyrin.
[0012] Experiments have shown that long-chain polyunsaturated fatty
acids ("LC-PUFAs") are absorbed more readily in the form of
triglycerides ("TG"). Examples of LC-PUFAs include omega-3 fatty
acids such as eicosapentaenoic acid ("EPA"), and docosahexaenoic
acid ("DHA"), and omega-6 fatty acids such as gamma-linolenic acid
("GLA"), dihomo-gamma-linolenic acid ("DGLA"), and arachidonic acid
("ARA").
[0013] Experiments have also shown that monoglycerides ("MG") are
readily absorbed even from compromised GI tracts. There are two
types of MG, sn-2 and sn-1 (sn-3 and sn-1 are equivalent). Previous
work had shown that the fatty acid in the sn-2 position is absorbed
more quickly than the fatty acid in the sn-1 position when TG are
administered. MG as both forms, sn-1 and sn-2 are both readily
absorbed. The use of a MG will help to maximize lipid absorption
which can help to improve the transition from parenteral to enteral
support.
[0014] In an embodiment, the nutritional composition includes an
ingredient such as synbiotics, phytonutrients or a combination
thereof. Additional ingredients in the nutritional composition can
include lipids, carbohydrates, antioxidants, vitamins, minerals, or
a combination thereof.
[0015] In an embodiment, the nutritional composition includes one
or more fibers. The fiber can be galacto-oligosaccharides,
fructo-oligosaccharides, fuco-oligosaccharides,
xylo-oligosaccharides, palatinose-oligosaccharide, soybean
oligosaccharide, gentio-oligosaccharide, inulin, pectin, pectate,
alginate, chondroitine, hyaluronic acids, heparine, heparane,
sialoglycans, fucoidan, carrageenan, xanthan gum, cellulose,
polydextrose, guar gum, partially hydrolyzed guar gum or a
combination thereof.
[0016] In an embodiment, the nutritional composition includes one
or more probiotics. The probiotic can be Saccharomyces,
Debaromyces, Candida, Pichia, Torulopsis, Aspergillus, Rhizopus,
Mucor, Penicillium, Torulopsis, Bifidobacterium, Bacteroides,
Clostridium, Fusobacterium, Melissococcus, Propionibacterium,
Streptococcus, Enterococcus, Lactococcus, Staphylococcus,
Peptostrepococcus, Bacillus, Pediococcus, Micrococcus, Leuconostoc,
Weissella, Aerococcus, Oenococcus, Lactobacillus or a combination
thereof. In another embodiment, the nutritional composition
includes one or more non-replicating microorganisms.
[0017] In an embodiment, the nutritional composition is in an
administrable form such as pharmaceutical formulations, nutritional
formulations, dietary supplements, functional foods and beverage
products.
[0018] In another embodiment, the present disclosure provides a
method of making a nutritional composition. The method comprises
combining one or more proteins, one or more amino acids and one or
more exogenous nucleotides to form a nutritional composition.
[0019] In an alternative embodiment, the present disclosure
provides a method of weaning a patient from parenteral nutrition
administration to enteral nutrition administration. The method
comprises administering to a patient having previously received
nutrition parenterally a weaning nutritional composition including
a protein, an amino acid and an exogenous nucleotide, and enterally
administering to the patient an enteral nutritional
composition.
[0020] In an embodiment, the method of weaning the patient
comprises administering about 500 mL of the weaning nutritional
composition during an initial 24 hour period before administering
the enteral nutritional composition in greater volume. The method
can further comprise administering about 750 mL of the weaning
nutritional composition during a second subsequent 24 hour period
before administering an enteral nutritional composition. The method
can further comprise administering about 1000 mL of the weaning
nutritional composition through a third subsequent 24 hour period
before administering an enteral nutritional composition for
additional days of feeding.
[0021] In yet another embodiment, the present disclosure provides a
method of providing nutrition to a patient. The method comprises
providing parenteral nutrition to a patient and administering to
the patient having previously received nutrition parenterally a
weaning nutritional composition comprising a protein, an amino acid
and an exogenous nucleotide. In another embodiment, the methods
include simultaneously administering to a patient receiving
nutrition parenterally, a weaning nutritional composition
comprising a protein, an amino acid and an exogenous nucleotide.
The parenteral nutrition can be total parenteral nutrition (e.g.,
no food is given by any other routes other than intravenously).
[0022] In an embodiment of any of the methods, the protein is an
intact protein, free amino acids, a whey protein hydrolysate,
casein hydrolysate, milk protein hydrolysate, soy protein
hydrolysate, pea protein hydrolysate or a combination thereof. The
protein can range from about 35% to about 55% of the total energy
of the nutritional composition.
[0023] In an embodiment of any of the methods, the amino acid is
from a glutamine source, a threonine source, a cysteine source, a
serine source, a proline source, or a combination thereof. The
glutamine source can be a glutamine dipeptide, a glutamine enriched
wheat protein or a combination thereof. The amino acid can be in an
amount from about 20 grams to about 40 grams in the nutritional
composition.
[0024] In an embodiment of any of the methods, the exogenous
nucleotide is in a monomeric form such as 5' Adenosine
Monophosphate, 5'-Guanosine Monophosphate, 5'-Cytosine
Monophosphate, 5'-Uracil Monophosphate, 5'-Inosine Monophosphate,
5'-Thymine Monophosphate or a combination thereof. The exogenous
nucleotide can also be intact ribonucleic acid. The exogenous
nucleotide can be in an amount of about 1 to about 4 grams in the
nutritional composition.
[0025] In an embodiment of any of the methods, the nutritional
composition includes one or more lipids. The lipid can be short
chain triglycerides, medium chain triglycerides, long chain
triglycerides, fish oil, vegetable oil or a combination thereof. In
an embodiment, the lipids include tributyrin.
[0026] In an embodiment of any of the methods, the nutritional
composition includes an ingredient such as synbiotics,
phytonutrients or a combination thereof. Additional ingredients in
the nutritional composition can include lipids, carbohydrates,
antioxidants, vitamins, minerals or a combination thereof.
[0027] In an embodiment of any of the methods, the nutritional
composition includes one or more fibers. The fiber can be
galacto-oligosaccharides, fructo-oligosaccharides,
fuco-oligosaccharides, xylo-oligosaccharides,
palatinose-oligosaccharide, soybean oligosaccharide,
gentio-oligosaccharide, inulin, pectin, pectate, alginate,
chondroitine, hyaluronic acids, heparine, heparane, sialoglycans,
fucoidan, carrageenan, xanthan gum, cellulose, polydextrose, guar
gum, partially hydrolyzed guar gum or a combination thereof.
[0028] In an embodiment of any of the methods, the nutritional
composition includes one or more probiotics. The probiotic can be
Saccharomyces, Debaromyces, Candida, Pichia, Torulopsis,
Aspergillus, Rhizopus, Mucor, Penicillium, Torulopsis,
Bifidobacterium, Bacteroides, Clostridium, Fusobacterium,
Melissococcus, Propionibacterium, Streptococcus, Enterococcus,
Lactococcus, Staphylococcus, Peptostrepococcus, Bacillus,
Pediococcus, Micrococcus, Leuconostoc, Weissella, Aerococcus,
Oenococcus, Lactobacillus or a combination thereof. The probiotics
may include non-replicating microorganisms.
[0029] In an embodiment of any of the methods, the nutritional
composition is in an administrable form such as pharmaceutical
formulations, nutritional formulations, dietary supplements,
functional foods and beverage products.
[0030] An advantage of the present disclosure is to provide an
improved nutritional composition having proteins (e.g., intact
and/or hydrolyzed), amino acids and exogenous nucleotides.
[0031] Another advantage of the present disclosure is to provide a
method of making an improved nutritional composition for weaning
from total parenteral nutrition.
[0032] Yet another advantage of the present disclosure is to
provide a nutritional composition that assists a patient in weaning
from total parenteral nutrition to enteral nutrition with improved
tolerance.
[0033] Still another advantage of the present disclosure is to
provide a quicker transition to enteral nutrition for patients
receiving total parenteral nutrition.
[0034] Another advantage of the present disclosure is to provide a
reduced recovery time for a patient's normal digestive function
after changing from total parenteral nutrition to enteral
nutrition.
[0035] Additional features and advantages are described herein, and
will be apparent from the following Detailed Description.
DETAILED DESCRIPTION
[0036] As used herein, "about" is understood to refer to numbers in
a range of numerals. Moreover, all numerical ranges herein should
be understood to include all integer, whole or fractions, within
the range.
[0037] As used herein the term "amino acid" is understood to
include one or more amino acids. The amino acid can be, for
example, alanine, arginine, asparagine, aspartate, citrulline,
cysteine, glutamate, glutamine, glycine, histidine, hydroxyproline,
hydroxyserine, hydroxytyrosine, hydroxylysine, isoleucine, leucine,
lysine, methionine, phenylalanine, proline, serine, taurine,
threonine, tryptophan, tyrosine, valine, or combinations
thereof.
[0038] As used herein, "animal" includes, but is not limited to,
mammals, which include but is not limited to, rodents, aquatic
mammals, domestic animals such as dogs and cats, farm animals such
as sheep, pigs, cows and horses, and humans. Wherein the terms
"animal" or "mammal" or their plurals are used, it is contemplated
that it also applies to any animals that are capable of the effect
exhibited or intended to be exhibited by the context of the
passage.
[0039] As used herein, the term "antioxidant" is understood to
include any one or more of various substances such as beta-carotene
(a vitamin A precursor), vitamin C, vitamin E, and selenium) that
inhibit oxidation or reactions promoted by Reactive Oxygen Species
("ROS") and other radical and non-radical species. Additionally,
antioxidants are molecules capable of slowing or preventing the
oxidation of other molecules. Non-limiting examples of antioxidants
include astaxanthin, carotenoids, coenzyme Q10 ("CoQ10"),
flavonoids, glutathione Goji (wolfberry), hesperidin,
lactowolfberry, lignan, lutein, lycopene, polyphenols, selenium,
vitamin A, vitamin B.sub.1, vitamin B.sub.6, vitamin B.sub.12,
vitamin C, vitamin D, vitamin E, zeaxanthin, or combinations
thereof.
[0040] As used herein, "complete nutrition" includes nutritional
products and compositions that contain sufficient types and levels
of macronutrients (protein, fats and carbohydrates) and
micronutrients to be sufficient to be a sole source of nutrition
for the animal to which it is being administered to. Patients can
receive 100% of their nutritional requirements from such complete
nutritional compositions.
[0041] As used herein, "effective amount" is an amount that
prevents a deficiency, treats a disease or medical condition in an
individual or, more generally, reduces symptoms, manages
progression of the diseases or provides a nutritional,
physiological, or medical benefit to the individual. A treatment
can be patient- or doctor-related.
[0042] While the terms "individual" and "patient" are often used
herein to refer to a human, the invention is not so limited.
Accordingly, the terms "individual" and "patient" refer to any
animal, mammal or human having or at risk for a medical condition
that can benefit from the treatment.
[0043] As used herein, non-limiting examples of fatty acid
components of fish oils include docosahexaenoic acid ("DHA") and
eicosapentaenoic acid ("EPA"). Additional sources of DHA and EPA
include plant sources of omega 3, flaxseed, walnut, algae, and
krill.
[0044] As used herein, "food grade micro-organisms" means
micro-organisms that are used and generally regarded as safe for
use in food.
[0045] As used herein, "incomplete nutrition" includes nutritional
products or compositions that do not contain sufficient levels of
macronutrients (protein, fats and carbohydrates) or micronutrients
to be sufficient to be a sole source of nutrition for the animal to
which it is being administered to. Partial or incomplete
nutritional compositions can be used as a nutritional
supplement.
[0046] As used herein, "long term administrations" are preferably
continuous administrations for more than 6 weeks. Alternatively,
"short term administrations," as used herein, are continuous
administrations for less than 6 weeks.
[0047] As used herein, "mammal" includes, but is not limited to,
rodents, aquatic mammals, domestic animals such as dogs and cats,
farm animals such as sheep, pigs, cows and horses, and humans.
Wherein the term "mammal" is used, it is contemplated that it also
applies to other animals that are capable of the effect exhibited
or intended to be exhibited by the mammal.
[0048] The term "microorganism" is meant to include the bacterium,
yeast and/or fungi, a cell growth medium with the microorganism, or
a cell growth medium in which microorganism was cultivated.
[0049] As used herein, the term "minerals" is understood to include
boron, calcium, chromium, copper, iodine, iron, magnesium,
manganese, molybdenum, nickel, phosphorus, potassium, selenium,
silicon, tin, vanadium, zinc, or combinations thereof.
[0050] As used herein, a "non-replicating" microorganism means that
no viable cells and/or colony forming units can be detected by
classical plating methods. Such classical plating methods are
summarized in the microbiology book: James Monroe Jay, et al.,
Modern food microbiology, 7th edition, Springer Science, New York,
N. Y. p. 790 (2005). Typically, the absence of viable cells can be
shown as follows: no visible colony on agar plates or no increasing
turbidity in liquid growth medium after inoculation with different
concentrations of bacterial preparations (non replicating' samples)
and incubation under appropriate conditions (aerobic and/or
anaerobic atmosphere for at least 24 h). For example,
bifidobacteria such as Bifidobacterium longum, Bifidobacterium
lactis and Bifidobacterium breve or lactobacilli, such as
Lactobacillus paracasei or Lactobacillus rhamnosus, may be rendered
non-replicating by heat treatment, in particular low
temperature/long time heat treatment.
[0051] As used herein, a "nucleotide" is understood to be a subunit
of deoxyribonucleic acid ("DNA"), ribonucleic acid ("RNA"),
polymeric RNA, polymeric DNA, or combinations thereof. It is an
organic compound made up of a nitrogenous base, a phosphate
molecule, and a sugar molecule (deoxyribose in DNA and ribose in
RNA). Individual nucleotide monomers (single units) are linked
together to form polymers, or long chains. Exogenous nucleotides
are specifically provided by dietary supplementation. The exogenous
nucleotide can be in a monomeric form such as, for example,
5'-Adenosine Monophosphate ("5'-AMP"), 5'-Guanosine Monophosphate
("5'-GMP"), 5'-Cytosine Monophosphate ("5'-CMP"), 5'-Uracil
Monophosphate ("5'-UMP"), 5'-Inosine Monophosphate ("5'-IMP"),
5'-Thymine Monophosphate ("5'-TMP"), or combinations thereof. The
exogenous nucleotide can also be in a polymeric form such as, for
example, an intact RNA. There can be multiple sources of the
polymeric form such as, for example, yeast RNA.
[0052] "Nutritional products," or "nutritional compositions," as
used herein, are understood to include any number of optional
additional ingredients, including conventional food additives, for
example one or more acidulants, additional thickeners, buffers or
agents for pH adjustment, chelating agents, colorants, emulsifies,
excipient, flavor agent, mineral, osmotic agents, a
pharmaceutically acceptable carrier, preservatives, stabilizers,
sugar, sweeteners, texturizers, and/or vitamins. The optional
ingredients can be added in any suitable amount. The nutritional
products or compositions may be a source of complete nutrition or
may be a source of incomplete nutrition.
[0053] As used herein the term "patient" is understood to include
an animal, especially a mammal, and more especially a human that is
receiving or intended to receive treatment, as it is herein
defined.
[0054] As used herein, "phytochemicals" or "phytonutrients" are
non-nutritive compounds that are found in many foods.
Phytochemicals are functional foods that have health benefits
beyond basic nutrition, are health promoting compounds that come
from plant sources, and may be natural or purified.
"Phytochemicals" and "Phytonutrients" refers to any chemical
produced by a plant that imparts one or more health benefit on the
user. Non-limiting examples of phytochemicals and phytonutrients
include those that are:
[0055] i) phenolic compounds which include monophenols (such as,
for example, apiole, carnosol, carvacrol, dillapiole, rosemarinol);
flavonoids (polyphenols) including flavonols (such as, for example,
quercetin, fingerol, kaempferol, myricetin, rutin, isorhamnetin),
flavanones (such as, for example, fesperidin, naringenin, silybin,
eriodictyol), flavones (such as, for example, apigenin, tangeritin,
luteolin), flavan-3-ols (such as, for example, catechins,
(+)-catechin, (+)-gallocatechin, (-)-epicatechin,
(-)-epigallocatechin, (-)-epigallocatechin gallate (EGCG),
(-)-epicatechin 3-gallate, theaflavin, theaflavin-3 -gallate,
theaflavin-3'-gallate, theaflavin-3,3'-digallate, thearubigins),
anthocyanins(flavonals) and anthocyanidins (such as, for example,
pelargonidin, peonidin, cyanidin, delphinidin, malvidin,
petunidin), isoflavones(phytoestrogens) (such as, for example,
daidzein(formononetin), genistein(biochanin A), glycitein),
dihydroflavonols, chalcones, coumestans(phytoestrogens), and
Coumestrol; Phenolic acids (such as: Ellagic acid, Gallic acid,
Tannic acid, Vanillin, curcumin); hydroxycinnamic acids (such as,
for example, caffeic acid, chlorogenic acid, cinnamic acid, ferulic
acid, coumarin); lignans(phytoestrogens), silymarin,
secoisolariciresinol, pinoresinol and lariciresinol); tyrosol
esters (such as, for example, tyrosol, hydroxytyrosol, oleocanthal,
oleuropein); stilbenoids (such as, for example, resveratrol,
pterostilbene, piceatannol) and punicalagins;
[0056] ii) terpenes(isoprenoids) which include
carotenoids(tetraterpenoids) including carotenes (such as, for
example, .alpha.-carotene, .beta.-carotene, .gamma.-carotene,
.delta.-carotene, lycopene, neurosporene, phytofluene, phytoene),
and xanthophylls (such as, for example, canthaxanthin,
cryptoxanthin, aeaxanthin, astaxanthin, lutein, rubixanthin);
monoterpenes (such as, for example, limonene, perillyl alcohol);
saponins; lipids including: phytosterols (such as, for example,
campesterol, beta sitosterol, gamma sitosterol, stigmasterol),
tocopherols (vitamin E), and omega-3, 6, and 9 fatty acids (such
as, for example, gamma-linolenic acid); triterpenoid (such as, for
example, oleanolic acid, ursolic acid, betulinic acid, moronic
acid);
[0057] iii) betalains which include Betacyanins (such as: betanin,
isobetanin, probetanin, neobetanin); and betaxanthins (non
glycosidic versions) (such as, for example, indicaxanthin, and
vulgaxanthin);
[0058] iv) organosulfides, which include, for example,
dithiolthiones (isothiocyanates) (such as, for example,
sulphoraphane); and thiosulphonates (allium compounds) (such as,
for example, allyl methyl trisulfide, and diallyl sulfide),
indoles, glucosinolates, which include, for example,
indole-3-carbinol; sulforaphane; 3,3'-diindolylmethane; sinigrin;
allicin; alliin; allyl isothiocyanate; piperine;
syn-propanethial-S-oxide;
[0059] v) protein inhibitors, which include, for example, protease
inhibitors;
[0060] vi) other organic acids which include oxalic acid, phytic
acid (inositol hexaphosphate); tartaric acid; and anacardic acid;
or
[0061] vii) combinations thereof.
[0062] As used in this disclosure and the appended claims, the
singular forms "a," "an" and "the" include plural referents unless
the context clearly dictates otherwise. Thus, for example,
reference to "a polypeptide" includes a mixture of two or more
polypeptides, and the like.
[0063] As used herein, a "prebiotic" is a food substance that
selectively promotes the growth of beneficial bacteria or inhibits
the growth or mucosal adhesion of pathogenic bacteria in the
intestines. They are not inactivated in the stomach and/or upper
intestine or absorbed in the gastrointestinal tract of the person
ingesting them, but they are fermented by the gastrointestinal
microflora and/or by probiotics. Prebiotics are, for example,
defined by Glenn R. Gibson and Marcel B. Roberfroid, Dietary
Modulation of the Human Colonic Microbiota: Introducing the Concept
of Prebiotics, J. Nutr. 1995 125: 1401-1412. Non-limiting examples
of prebiotics include acacia gum, alpha glucan, arabinogalactans,
beta glucan, dextrans, fructooligosaccharides, fucosyllactose,
galactooligosaccharides, galactomannans, gentiooligosaccharides,
glucooligosaccharides, guar gum, inulin, isomaltooligosaccharides,
lactoneotetraose, lactosucrose, lactulose, levan, maltodextrins,
milk oligosaccharides, partially hydrolyzed guar gum,
pecticoligosaccharides, resistant starches, retrograded starch,
sialooligosaccharides, sialyllactose, soyoligosaccharides, sugar
alcohols, xylooligosaccharides, or their hydrolysates, or
combinations thereof.
[0064] As used herein, probiotic micro-organisms (hereinafter
"probiotics") are food-grade microorganisms (alive, including
semi-viable or weakened, and/or non-replicating), metabolites,
microbial cell preparations or components of microbial cells that
could confer health benefits on the host when administered in
adequate amounts, more specifically, that beneficially affect a
host by improving its intestinal microbial balance, leading to
effects on the health or well-being of the host. See, Salminen S,
Ouwehand A. Benno Y. et al., Probiotics: how should they be
defined?, Trends Food Sci. Technol. 1999:10, 107-10. In general, it
is believed that these micro-organisms inhibit or influence the
growth and/or metabolism of pathogenic bacteria in the intestinal
tract. The probiotics may also activate the immune function of the
host. For this reason, there have been many different approaches to
include probiotics into food products. Non-limiting examples of
probiotics include Aerococcus, Aspergillus, Bacteroides,
Bifidobacterium, Candida, Clostridium, Debaromyces, Enterococcus,
Fusobacterium, Lactobacillus, Lactococcus, Leuconostoc,
Melissococcus, Micrococcus, Mucor, Oenococcus, Pediococcus,
Penicillium, Peptostrepococcus, Pichia, Propionibacterium,
Pseudocatenulatum, Rhizopus, Saccharomyces, Staphylococcus,
Streptococcus, Torulopsis, Weissella, or combinations thereof.
[0065] The terms "protein," "peptide," "oligopeptides" or
"polypeptide," as used herein, are understood to refer to any
composition that includes, a single amino acids (monomers), two or
more amino acids joined together by a peptide bond (dipeptide,
tripeptide, or polypeptide), collagen, precursor, homolog, analog,
mimetic, salt, prodrug, metabolite, or fragment thereof or
combinations thereof. For the sake of clarity, the use of any of
the above terms is interchangeable unless otherwise specified. It
will be appreciated that polypeptides (or peptides or proteins or
oligopeptides) often contain amino acids other than the 20 amino
acids commonly referred to as the 20 naturally occurring amino
acids, and that many amino acids, including the terminal amino
acids, may be modified in a given polypeptide, either by natural
processes such as glycosylation and other post-translational
modifications, or by chemical modification techniques which are
well known in the art. Among the known modifications which may be
present in polypeptides of the present invention include, but are
not limited to, acetylation, acylation, ADP-ribosylation,
amidation, covalent attachment of a flavanoid or a heme moiety,
covalent attachment of a polynucleotide or polynucleotide
derivative, covalent attachment of a lipid or lipid derivative,
covalent attachment of phosphatidylinositol, cross-linking,
cyclization, disulfide bond formation, demethylation, formation of
covalent cross-links, formation of cystine, formation of
pyroglutamate, formylation, gamma-carboxylation, glycation,
glycosylation, glycosylphosphatidyl inositol ("GPI") membrane
anchor formation, hydroxylation, iodination, methylation,
myristoylation, oxidation, proteolytic processing, phosphorylation,
prenylation, racemization, selenoylation, sulfation, transfer-RNA
mediated addition of amino acids to polypeptides such as
arginylation, and ubiquitination. The term "protein" also includes
"artificial proteins" which refers to linear or non-linear
polypeptides, consisting of alternating repeats of a peptide.
[0066] Non-limiting examples of proteins include dairy based
proteins, plant based proteins, animal based proteins and
artificial proteins. Dairy based proteins include, for example,
intact proteins, amino acids, casein, caseinates (e.g., all forms
including sodium, calcium, potassium caseinates), casein
hydrolysates, whey (e.g., all forms including concentrate, isolate,
demineralized), whey hydrolysates, milk protein concentrate, and
milk protein isolate. Plant based proteins include, for example,
soy protein (e.g., all forms including concentrate and isolate),
pea protein (e.g., all forms including concentrate and isolate),
canola protein (e.g., all forms including concentrate and isolate),
other plant proteins that commercially are wheat and fractionated
wheat proteins, corn and it fractions including zein, rice, oat,
potato, peanut, green pea powder, green bean powder, and any
proteins derived from beans, lentils, and pulses. Animal based
proteins may include, for example, beef, poultry, fish, lamb,
seafood, or combinations thereof.
[0067] All dosage ranges contained within this application are
intended to include all numbers, whole or fractions, contained
within said range.
[0068] As used herein, a "synbiotic" is a supplement that contains
both a prebiotic and a probiotic that work together to improve the
microflora of the intestine.
[0069] As used herein, the terms "treatment," "treat" and "to
alleviate" include both prophylactic or preventive treatment (that
prevent and/or slow the development of a targeted pathologic
condition or disorder) and curative, therapeutic or
disease-modifying treatment, including therapeutic measures that
cure, slow down, lessen symptoms of, and/or halt progression of a
diagnosed pathologic condition or disorder; and treatment of
patients at risk of contracting a disease or suspected to have
contracted a disease, as well as patients who are ill or have been
diagnosed as suffering from a disease or medical condition. The
term does not necessarily imply that a subject is treated until
total recovery. The terms "treatment" and "treat" also refer to the
maintenance and/or promotion of health in an individual not
suffering from a disease but who may be susceptible to the
development of an unhealthy condition, such as nitrogen imbalance
or muscle loss. The terms "treatment," "treat" and "to alleviate"
are also intended to include the potentiation or otherwise
enhancement of one or more primary prophylactic or therapeutic
measure. The terms "treatment," "treat" and "to alleviate" are
further intended to include the dietary management of a disease or
condition or the dietary management for prophylaxis or prevention a
disease or condition.
[0070] As used herein, a "tube feed" is a complete or incomplete
nutritional product or composition that is administered to an
animal's gastrointestinal system, other than through oral
administration, including but not limited to a nasogastric tube,
orogastric tube, gastric tube, jejunostomy tube ("J-tube"),
percutaneous endoscopic gastrostomy ("PEG"), port, such as a chest
wall port that provides access to the stomach, jejunum and other
suitable access ports.
[0071] As used herein the term "vitamin" is understood to include
any of various fat-soluble or water-soluble organic substances
(non-limiting examples include vitamin A, Vitamin B1 (thiamine),
Vitamin B2 (riboflavin), Vitamin B3 (niacin or niacinamide),
Vitamin B5 (pantothenic acid), Vitamin B6 (pyridoxine, pyridoxal,
or pyridoxamine, or pyridoxine hydrochloride), Vitamin B7 (biotin),
Vitamin B9 (folic acid), and Vitamin B12 (various cobalamins;
commonly cyanocobalamin in vitamin supplements), vitamin C, vitamin
D, vitamin E, vitamin K, K1 and K2 (i.e. MK-4, MK-7), folic acid
and biotin) essential in minute amounts for normal growth and
activity of the body and obtained naturally from plant and animal
foods or synthetically made, pro-vitamins, derivatives,
analogs.
[0072] Nutritional compositions for weaning from total parenteral
nutrition to enteral nutrition and methods of making and using the
nutritional compositions are provided. The nutritional composition
in embodiments of the present disclosure can support the GI tract
during the transition from total parenteral nutrition to enteral
nutrition so that there is a more effective weaning from total
parenteral nutrition. This can be achieved by including several GI
trophic ingredients that enable the small and large bowels to
recover from the atrophy that occurred during total parenteral
nutrition and resume functioning more quickly.
[0073] By administering the nutritional compositions in embodiments
of the present disclosure, the rate of enteral feeding can be
increased more quickly and the total parenteral nutrition
discontinued sooner. This can allow for faster recovery of a
patient's normal digestive function and a quicker hospital
discharge for patients who were receiving total parenteral
nutrition.
[0074] In a general embodiment, the nutritional composition
includes one or more proteins, one or more amino acids and one or
more exogenous nucleotides. The combination of specific proteins,
amino acids and exogenous nucleotides can assist a patient (e.g.,
child, teenage, adult, elderly, animal) in weaning from total
parenteral nutrition to enteral nutrition with improved
tolerance.
[0075] In an embodiment, the nutritional composition has a low to
moderate caloric density (e.g., 0.5-1.2 Kcal/mL) and provides a low
to moderate feeding from about 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1,
or 1.2 Kcal/mL. It should be appreciated that any two amounts of
the caloric density recited herein can further represent end points
in a preferred range of the caloric densities of the nutritional
composition. For example, the amounts of 0.7 and 0.9 Kcal/mL can
represent the individual amounts of the caloric densities as well
as a preferred range of the caloric densities between about 0.6 and
0.9 Kcal/mL.
[0076] The feeding volume may range depending on the size and
weight of the patient or the patient's specific nutritional needs.
For example, the feeding volumes may be anywhere between 100 ml to
1500 ml. The feeding volumes may be 100, 200, 300, 400, 500, 600,
700, 800, 900, 1000, 1100, 1200, 1300, 1400 and 1500. It should be
appreciated that any two amounts of the feeding volumes recited
herein can further represent end points in a preferred range of the
feeding volumes of the nutritional composition. For example, the
amounts of 600 ml and 1100 ml can represent the individual amounts
of the feeding volumes as well as a preferred range of the feeding
amounts between about 500 ml and about 1000 ml.
[0077] The macronutrient profile of the nutritional composition in
an embodiment can be as follows: proteins--from about 35% to about
55% of the total energy; lipids--from about 20% to about 30% of the
total energy; and carbohydrates--from about 15% or 20% to about 45%
of the total energy of the nutritional composition.
[0078] The protein can mainly be provided as a hydrolysate. The
protein can be a whey protein hydrolysate, casein hydrolysate, milk
protein hydrolysate, soy protein hydrolysate, pea protein
hydrolysate or a combination thereof. Whey protein, a preferred
protein, is intrinsically rich in threonine and cysteine. However,
additional amounts of threonine and/or soluble cysteine precursors
(e.g., acetylcysteine, cystathionine) can be added as the amino
acid as well. The protein may also be an intact protein, or free
amino acids such as, but not limited to cysteine, or a source
thereof. Cysteine sources may include, but are not limited to
cystein-rich peptides, acetylcysteine, cystathionine, or
combinations thereof.
[0079] The hydrolysates can have a low to high degree of
hydrolysis. The hydrolysates contain a range of peptide sizes to
act as trophic agents for the small bowel and allow the use of all
intestinal transporter systems for peptides and amino acids thus
facilitating optimum absorption of protein.
[0080] In an embodiment, the protein ranges from about 35% to about
55% of the total energy of the nutritional composition. More
specifically, the amount of the protein can be about 35%, 40%, 45%,
50%, 55% and the like of the total energy. It should be appreciated
that any two amounts of the protein recited herein can further
represent end points in a preferred range of the protein in the
nutritional composition. For example, the amounts of 40% and 50% by
total energy can represent the individual amounts of the protein as
well as a preferred range of the protein between about 40% and
about 50% of the total energy.
[0081] The amino acid can be provided by a glutamine source, a
threonine source, a cysteine source, a serine source, a proline
source, or a combination thereof. The glutamine source can be a
glutamine dipeptide and/or glutamine enriched wheat protein.
Glutamine dipeptide can be included due to the use of glutamine by
enterocytes as an energy source. Glutamine dipeptide offers the
possibility of including glutamine in a liquid product. Threonine,
serine and proline are important amino acids for the production of
mucin. Mucin coats the GI tract and helps to protect it from
attachment of pathogens. Cysteine is a major precursor of
glutathione, which is key for the antioxidant defenses of the body
that are needed in case of reperfusion of the intestine.
[0082] The amino acid can be in the nutritional composition in an
amount ranging from about 20 grams to about 50 grams. More
specifically, the amino acid can be in the nutritional composition
in an amount of about 20 grams, 25 grams, 30 grams 35 grams, 40
grams, 45 grams, 50 grams and the like. It should be appreciated
that any two amounts of the amino acid recited herein can further
represent end points in a preferred range of the amino acid. For
example, the amounts of 30 grams and 45 grams can represent the
individual amounts of the amino acid in the nutritional composition
as well as a preferred range of the amino acid between about 35
grams and about 40 grams in the nutritional composition.
[0083] Nucleotides are low molecular weight biological molecules
key to biochemical processes. Sources include de novo synthesis,
recovery via salvage mechanisms, and dietary intakes. While
endogenous production serves as the main nucleotide source, there
is evidence to suggest that exogenous sources are important in
rapidly proliferating cells in the immune and gastrointestinal
systems (e.g., epithelial and immune cells), where they may become
conditionally essential. Exogenous nucleotides may support optimal
growth and function of metabolically active cells in times of
cellular insult and their supplementation may improve clinical
outcomes in the critically ill and immune suppressed patient. In
addition, non-protein nitrogen can come from nucleotides provided,
for example, as yeast RNA.
[0084] The exogenous nucleotides can be in the form of monomers and
polymers as part of the nutritional compositions. A nucleotide is a
subunit of deoxyribonucleic acid ("DNA") or ribonucleic acid
("RNA"). It is an organic compound made up of a nitrogenous base, a
phosphate molecule, and a sugar molecule (deoxyribose in DNA and
ribose in RNA). Individual nucleotide monomers (single units) are
linked together to form polymers, or long chains. The exogenous
nucleotides in embodiments of the present disclosure are
specifically provided by dietary supplementation.
[0085] The exogenous nucleotides can be in a monomeric form such
as, for example, 5' Adenosine Monophosphate ("5'-AMP"),
5'-Guanosine Monophosphate ("5'-GMP"), 5'-Cytosine Monophosphate
("5'-CMP"), 5'-Uracil Monophosphate ("5'-UMP"), 5'-Inosine
Monophosphate ("5'-IMP"), 5'-Thymine Monophosphate ("5'-TMP") or a
combination thereof. The exogenous nucleotides can also be in a
polymeric form such as, for example, an intact RNA. There can be
multiple sources of the polymeric form such as, for example, yeast
RNA.
[0086] The exogenous nucleotides can be in the nutritional
composition an amount of about 1 to about 4 grams. More
specifically, the exogenous nucleotides can be in the nutritional
composition in an amount of about 1 gram, 1.2 grams, 1.4 grams, 1.6
grams, 1.8 grams, 2 grams, 2.2 grams, 2.4 grams, 2.6 grams, 2.8
grams, 3 grams, 3.2 grams, 3.4 grams, 3.6 grams, 3.8 grams, 4 grams
and the like. It should be appreciated that any two amounts of the
exogenous nucleotides recited herein can further represent end
points in a preferred range of the exogenous nucleotides. For
example, the amounts of 1.8 grams and 3.4 grams can represent the
individual amounts of the exogenous nucleotides in the nutritional
composition as well as a preferred range of the exogenous
nucleotides between about 1.4 grams and about 3 grams in the
nutritional composition.
[0087] Additional ingredients may be used with the proteins, amino
acids and exogenous nucleotides to assist in the weaning process.
In an embodiment, the nutritional composition includes one or more
lipids. The lipid can be short chain triglycerides, medium chain
triglycerides ("MCTs"), long chain triglycerides ("LCTs"), fish
oil, vegetable oil or a combination thereof. The fish oils can
include docosahexaenoic acid ("DHA") and eicosapentaenoic acid
("EPA"). The vegetable oils can be, for example, canola oil,
sunflower oil, safflower oil, corn oil, coconut oil, palm oil and
soybean oil. In an embodiment, the lipids include tributyrin.
[0088] The lipid component can contain a high proportion of MCTs
that are easy to absorb. As a total parenteral nutrition weaning
composition, the content of essential fatty acids does not need to
meet the typical daily long term needs of a human. Fish oil at a
level to provide about 2 grams to about 3 grams of EPA and DHA
serve to help control the inflammation associated with the
ischemia/reperfusion associated with re-feeding of the GI tract.
The overall n6:n3 ratio can be no higher than 5:1.
[0089] In an embodiment, the nutritional composition includes one
or more fibers. The fiber can be galacto-oligosaccharides,
fructo-oligosaccharides, fuco-oligosaccharides,
xylo-oligosaccharides, palatinose-oligosaccharide, soybean
oligosaccharide, gentio-oligosaccharide, inulin, pectin, pectate,
alginate, chondroitine, hyaluronic acids, heparine, heparane,
sialoglycans, fucoidan, carrageenan, xanthan gum, cellulose,
polydextrose, partially hydrolyzed guar gum, guar gum or a
combination thereof. Partially hydrolyzed guar gum, for example,
has been proven to reduce the incidence of diarrhea in critical
care patients. Fiber can be added as an optional ingredient as a
means to improve feeding tolerance. If fiber is used, the fiber
should be in an amount that prevents or minimizes intestinal
discomfort.
[0090] In an embodiment, the nutritional composition includes one
or more probiotics. The probiotic can be Saccharomyces,
Debaromyces, Candida, Pichia, Torulopsis, Aspergillus, Rhizopus,
Mucor, Penicillium, Torulopsis, Bifidobacterium, Bacteroides,
Clostridium, Fusobacterium, Melissococcus, Propionibacterium,
Streptococcus, Enterococcus, Lactococcus, Staphylococcus,
Peptostrepococcus, Bacillus, Pediococcus, Micrococcus, Leuconostoc,
Weissella, Aerococcus, Oenococcus, Lactobacillus or a combination
thereof. The probiotics may also include non-replicating
microorganisms.
[0091] The nutritional composition can further include ingredients
such as synbiotics, phytonutrients or a combination thereof. As
used herein, a synbiotic is a supplement that contains both a
prebiotic and a probiotic that work together to improve the
microflora of the intestine. Non-limiting examples of
phytonutrients include quercetin, curcumin, limonin, carotenoids,
lutein, lycopene, etc.
[0092] Additional ingredients in the nutritional composition can
include lipids, carbohydrates, antioxidants, vitamins, minerals or
a combination thereof. Carbohydrates include various
monosaccharides, disaccharides, oligosaccharides, and
polysaccharides. Suitable carbohydrates include, for example, fast
digesting maltodextrin, starch, corn syrup, glucose, sucrose,
lactose, etc.
[0093] Antioxidants are molecules capable of slowing or preventing
the oxidation of other molecules. Non-limiting examples of
antioxidants include vitamin A, carotenoids, vitamin C, vitamin E,
selenium, flavonoids, polyphenols, lycopene, lutein, lignan,
coenzyme Q10 ("CoQ10") and glutathione.
[0094] Non-limiting examples of vitamins may include Vitamins A,
B-complex (such as B-1, B-2, B-6 and B-12), C, D, E and K, niacin
and acid vitamins such as pantothenic acid and folic acid and
biotin. Non-limiting examples of minerals may include calcium,
iron, zinc, magnesium, iodine, copper, phosphorus, manganese,
potassium, chromium, molybdenum, selenium, nickel, tin, silicon,
vanadium and boron.
[0095] Vitamin C can be preferably used in the nutritional
compositions for collagen synthesis, stimulation of interferon,
maintenance of redox integrity of the cell and intracellular matrix
components. Vitamin E can be preferably used in the nutritional
compositions as a lipid soluble antioxidant that stabilizes cell
membranes and prevents oxidative damage to immune cells. Selenium
can be preferably used in the nutritional compositions as a
component of selenoproteins to augment cellular immune response
through production of interferon an earlier peak of T cell
proliferation and increased T helper cells.
[0096] With the occurrence of ischemia/reperfusion, there is
oxidative stress that could be met by a high level of antioxidant
nutrients in embodiments of the nutritional composition. Vitamins C
and E can be provided at two to ten times the accepted daily need
of a healthy adult. In an embodiment, vitamin C is provided at four
times the accepted daily need of a healthy adult, and vitamin E is
provided at eight times the accepted daily need of a healthy adult.
Selenium can also be provided at two or more times the daily
requirement of a healthy adult. In an embodiment, selenium is
provided at three times the daily requirement of a healthy
adult.
[0097] Other optional ingredients (e.g., colors, flavors, spices,
herbs, etc.) can be added to make the nutritional composition
sufficiently palatable. The optional ingredients can be added in
any suitable amount.
[0098] In an alternative embodiment, the present disclosure
provides a method of weaning a patient from parenteral nutrition
administration to enteral nutrition administration. The method
comprises administering to a patient having previously received
nutrition parenterally a weaning nutritional composition including
a protein, an amino acid and an exogenous nucleotide, and enterally
administering to the patient an enteral nutritional composition.
The parenteral nutrition administration can be total parenteral
nutrition administration (e.g., no food is given by any other
routes other than intravenously). In yet another embodiment,
methods of weaning a patient from parenteral administration to
enteral nutrition administration. The method comprises
administering to a patient undergoing a parenteral diet regimen a
weaning nutritional compsoition including a protein, an amino acid
and an exogenous nucleotide.
[0099] In an embodiment, the method of weaning the patient
comprises administering about 500 mL of the weaning nutritional
composition during an initial 24 hour period before enterally
administering longer term a enteral nutritional composition. The
method can further comprise administering about 750 mL of the
weaning nutritional composition during a second subsequent 24 hour
period before enterally administering longer term a enteral
nutritional composition. The method can further comprise
administering about 1000 mL of the weaning nutritional composition
through a third subsequent 24 hour period before enterally
administering longer term a enteral nutritional composition.
[0100] In yet another embodiment, the present disclosure provides a
method of providing nutrition to a patient. The method comprises
providing parenteral nutrition to a patient and administering to
the patient having previously received nutrition parenterally a
weaning nutritional composition comprising a protein, an amino acid
and an endogenous nucleotide. The parenteral nutrition can be total
parenteral nutrition.
[0101] Using any of the nutritional compositions previously
described in embodiments of the present methods, the rate of
enteral feeding should be able to be increased more quickly in a
patient and the parenteral nutrition or total parenteral nutrition
discontinued sooner. This is expected to allow for faster recovery
of normal function and hospital discharge of the patient.
EXAMPLES
[0102] By way of example and not limitation, the following examples
are illustrative of various embodiments of the present disclosure.
The formulations below are provided for exemplification only, and
they can be modified by the skilled artisan to the necessary
extent, depending on the special features that are desired. All
percentages herein are based on the total weight of the composition
unless noted otherwise.
Example 1
TABLE-US-00001 [0103] Nutritional composition formulation #1 Volume
1,000 mL Caloric density 0.7 kcal/mL Calories 700 Protein,
including AA* 50% of energy (includes dipeptide), whey hydrolysate
Glutamine (as Ala-Gln) 20 g/L Threonine 3.0 g/L Nucleotides 1.5 g/L
Carbohydrates 30% of energy Lipids 20% of energy N6:N3 maximum of
5:1 MCT:LCT 40:60 Vitamins & minerals Meet daily recommended
intake ("DRI") and safe and adequate levels in 1,000 mL (2 times
the DRI for vitamins C and E and selenium) Fiber Without soluble or
insoluble fiber that may cause bloating, etc. *AA = amino acids
Example 2
TABLE-US-00002 [0104] Nutritional composition formulation #2 Volume
1,000 mL Caloric density 0.7 kcal/mL Calories 700 Protein,
including AA* 50% of energy, whey hydrolysate Glutamine (as
Ala-Gln) 20 g/L Threonine 2.0 g/L Nucleotides 1.5 g/L Carbohydrates
30% of energy Lipids 20% of energy N6:N3 maximum of 5:1 MCT:LCT
40:60 Tributyrin 4.0 g/L Vitamins & minerals food for Special
Medical Purposes Fiber fiber free *AA = amino acids
Example 3
TABLE-US-00003 [0105] Nutritional composition formulation #3 Volume
1,000 mL Caloric density 0.7 kcal/mL Calories 700 Protein,
including AA* 55% of energy, whey hydrolysate Glutamine (as
Ala-Gln) 20 g/L Threonine 2.0 g/L Nucleotides 1.5 g/L Carbohydrates
20% of energy Lipids 25% of energy N6:N3 maximum of 5:1 MCT:LCT
40:60 Tributyrin 10.0 g/L Vitamins & minerals food for special
medical purposes Fiber fiber free *AA = amino acids
Example 4
TABLE-US-00004 [0106] Nutritional composition formulation #4 Volume
1,000 mL Caloric density 0.7 kcal/mL Calories 700 Protein,
including AA* 50% of energy, casein hydrolysate Glutamine (as
Ala-Gln) 20 g/L Threonine 2.0 g/L Cysteine 2.0 g/L Nucleotides 1.5
g/L Carbohydrates 25% of energy Lipids 25% of energy N6:N3 maximum
of 5:1 MCT:LCT 40:60 Vitamins & minerals food for special
medical purposes except for Vitamin C 380 mg Vitamin E 120 mg
Selenium 200 mcg Fiber fiber free *AA = amino acids
Example 5
TABLE-US-00005 [0107] Nutritional composition formulation #5 Volume
1,000 mL Caloric density 0.8 kcal/mL Calories 800 Protein,
including AA* 50% of energy, casein Glutamine (as Ala-Gln) 20 g/L
Threonine 2.0 g/L Nucleotides 1.5 g/L Carbohydrates 30% of energy
Lipids 20% of energy N6:N3 maximum of 5:1 MCT:LCT 40:60 Vitamins
& minerals food for special medical purposes except for Vitamin
C 380 mg Vitamin E 120 mg Selenium 200 mcg Fiber fiber free *AA =
amino acids
Examples 6 - 9
[0108] Examples 6 to 9 include the formulations of Examples 2 to 5,
respectively, but wherein the protein source (e.g., whey
hydrolysate, casein hydrolysate or casein) includes dipeptides.
[0109] It should be understood that various changes and
modifications to the presently preferred embodiments described
herein will be apparent to those skilled in the art. Such changes
and modifications can be made without departing from the spirit and
scope of the present subject matter and without diminishing its
intended advantages. It is therefore intended that such changes and
modifications be covered by the appended claims.
* * * * *